We have organized a consortium to focus on the development of new therapies for Renal Carcinoma. Members are at 4 institutions: UCLA, Roswell Park Memorial Institute, University of Rochester, and Mayo Clinic. Dr. Jean B. deKernion is chairman. This application seeks support for our initial project. A pilot clinical investigation of Specific Immunotherapy for Renal Carcinoma has been completed by one of us (McCune). The results are highly promising in that objective regressions occurred in 5/16 patients and 5 have survived 20 months or greater. Presently, it has not been established in any large scale randomized clinical trial that Specific Immunotherapy can produce a meaningful rate of regressions or significantly effect survival. Our preliminary study supports the hypothesis that Renal Carcinoma is a particularly suitable clinical setting in which to test this concept of treatment, and we propose now to do the following: (1) Confirm or refute our reported observation that objective regressions of metastatic renal carcinoma can be induced by specific immunotherapy methods described herein. (2) Determine by a prospectively randomized clinical trial whether or not this defined method of treatment has a meaningful effect on survival. (3) Evaluate certain parameters potentially useful in selecting appropriate patients for immunotherapy (DNCB skin test, ambulatory status) or required for success (dose). (4) Expand our clinical knowledge of a new problem: The polyclonality of metastases. If this concept is found to be a valid problem in the human setting, it represents an important dimension requiring additional basic research as we plan for future therapies. The methods involved require the use of autologous tumor cells obtained at nephrectomy and cryopreserved in liquid nitrogen. Patients receive weekly intradermal immunizations containing irradiated autologous tumor cells with C. parvum added as the adjuvant. Side effects in the pilot study have been negligble. If the regressions and patient benefits seen in our pilot study are substantiated in this current project, it would provide major evidence in support of the potential role of immunologic therapies.